DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 3, 12 and 18 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 3,12 and 18 recite the limitation "the model" in line 4 of each of the claims. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 2-6, 11, 12, 17 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Tockman et al (U.S. Patent Application Publication Number: US 2006/0047333 A1, hereinafter “Tockman”) in view of Rothenberg (U.S. Patent Number: US 7794407, hereinafter “Rothenberg”- PREVIOUSLY CITED) OR Katims (U.S. Patent Number: US 5078678, hereinafter “Katims”- PREVIOUSLY CITED).
Regarding claims 2, 11 and 17, Tockman teaches a method (e.g. [0033],[0034]) comprising:
advancing a lead through tissue of a patient that is outside the heart to a position on an inner surface of an innermost intercostal muscle and into a cavity of the mediastinum, the tissue having a plurality of tissue planes (e.g. [0014]: The lead introducer may be configured to guide the lead to an epicardial surface of a patient's heart. [0043], Fig.2 shows a lead 410 that is advanced through tissue of a patient outside the heart to inner surface of an innermost intercostal muscle and into the cavity of the mediastinum);
detecting, by a sensor during the advancing through the tissue planes, a sudden change in intrinsic electrical energy generated by the heart and/or other anatomical structures (e.g. [0015] The implant site is determined to be suitable or unsuitable for implantation of the cardiac lead based at least in part on the presence or absence of the anatomical feature or the physiological parameter., [0016] The physiological parameter may be a pacing threshold, an R-wave, or tissue impedance, for example).
While Tockman teaches a sensor at a distal end of the epicardial lead and that the sensor is used to guide the implantation of the lead at a desired target location and they teach that the Doppler flow sensor or an impedance sensor is a non-limiting example and other suitable sensors may be used (e.g. [0049]) and that the implant site is determined to be suitable or unsuitable for implantation of the cardiac lead based at least in part on the presence or absence of the anatomical feature or the physiological parameter and that the physiological parameter may be a pacing threshold, an R-wave, or tissue impedance, they do not specifically teach identifying advancement of a lead into a different tissue plane outside of the heart based on a sudden change in the intrinsic electrical energy detected by the sensor; and determining a location of a distal end of the lead outside of the heart based at least on the intrinsic electrical energy detected by the sensor.
In a similar field of endeavor, Rothenberg teaches a catheter system (e.g. 100 Fig. 1) with a lead body (e.g. 130 Fig. 1) comprising electrodes (e.g. 150, 152, 154, 156 Fig.1) that are disposed at a distal end and used to locate the tip of a catheter (e.g. Col.1, lines 7-11) inside the superior vena cava, right atrium, and/or right ventricle using information obtained from an electrocardiogram (i.e. intrinsic energy of the heart e.g. col.1 lines 60- col. 2 line 13, claim 1). Rothenberg further teaches that the sensed ECG waveforms are compared and that that the deflection of the trace, i.e., its vertical height relative to the baseline may be used to compare the P waves of the proximal and distal anode/cathode pairs. The deflection of the trace may also be used to compare the P waves of the proximal anode/cathode pair and/or distal anode/cathode pair to the reference anode/cathode pair (e.g. Col. 7 line 44-col. 8 line 38).
Additionally in a similar field of endeavor, Katims teaches a system and method for locating a distal end of a probe that is being implanted in a heart (e.g. Abstract). They teach a sensor (e.g. 104,105 Fig.3) at a distal end of the probe and monitoring the electrical characteristics of the tissue and a controller to identify the advancement of a distal end of the probe to a different tissue plane by identifying a sudden change in the electrical energy detected by the sensor and determine the location of the distal end of the lead based on identifying a sudden change in the electrical energy detected by the sensor (e.g. Fig. 4, 5A-D show that a distal end of a probe being inserted into the tissue and the P waves at different planes (designated by the dashed line at A, B, C, D in the reproduced figure below) are being monitored (i.e. the control unit 50 comprises an algorithm that locates the distal end of the probe based on the amplitude of the P-wave e.g. Col. 8 lines 18-64).
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Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to modify the system of Tockman to further modify the controller to identify the advancement of a distal end of the lead through the tissue as taught by Rothenberg OR Katims in order to provide the predictable results of obtaining a more accurate location of distal end of the lead from a specific site in the tissue.
Regarding claims 3, 12 and 18, Tockman in view of Rothenberg OR Katims teaches the claimed invention as discussed above except for determining an effect that tissue in the vicinity of the sensor has on electromagnetic waves of the intrinsic electrical energy; and comparing the effect with the model to determine advancement into the different tissue plane.
In a similar field of endeavor, Rothenberg further teaches that the sensed ECG waveforms are compared and that the deflection of the trace, i.e., its vertical height relative to the baseline may be used to compare the P waves of the proximal and distal anode/cathode pairs. The deflection of the trace may also be used to compare the P waves of the proximal anode/cathode pair and/or distal anode/cathode pair to the reference anode/cathode pair (e.g. Col. 7 line 44-col. 8 line 38) and therefore they teach determining an effect that tissue in the vicinity of the sensor has on electromagnetic waves of the intrinsic electrical energy; and comparing the effect with the model to determine advancement into the different tissue plane (Note: the claim does not recite any specific limitation regarding any model) in order to determine the location of the distal end of the lead as it advances into a different tissue plane.
Additionally Katims further teaches that the algorithm is programmed to detect changes in the P wave potentials as the catheter tip is moved and compare it to a threshold value and send a trigger signal at the threshold value and therefore they teach the controller is further configured to compare the electrical energy detected by the sensor with a model (i.e. This algorithm is programed to detect a predetermined percentage decrease in the p-WAVE potentials as the catheter tip 10 moves from location C to location B and at such a value trigger the monitor to indicate to the physician P to stop movement of the catheter 1-- as it is now in the correct location. predetermined changes, e.g. Fig. 4, 5A-D show that a distal end of a probe being inserted into the tissue and the P waves at different planes (designated by the dashed line at A, B, C, D in the reproduced figure above) are being monitored (i.e. the control unit 50 comprises an algorithm that locates the distal end of the probe based on the amplitude of the P-wave e.g. Col. 8 lines 18-64 Note: the claim does not recite any specific limitation regarding any model).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to modify the system of Tockman to further determine an effect that tissue in the vicinity of the sensor has on electromagnetic waves of the intrinsic electrical energy and compare the effect with the model to determine advancement into the different tissue plane as taught by Rothenberg OR Katims in order to provide the predictable results of obtaining a more accurate location of distal end of the lead from a specific site in the tissue.
Regarding claims 4-6, Tockman in view of Rothenberg OR Katims teaches the claimed invention as discussed above and Tockman further teaches inserting the lead into an intercostal space of the patient wherein the intercostal space is a side of the sternum and therefore “associated with” the cardiac notch (e.g. Fig.1).
Claims 7-9, 13-15 and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Tockman et al (U.S. Patent Application Publication Number: US 2006/0047333 A1, hereinafter “Tockman”) in view of Rothenberg (U.S. Patent Number: US 7794407, hereinafter “Rothenberg”- PREVIOUSLY CITED) OR Katims (U.S. Patent Number: US 5078678, hereinafter “Katims”- PREVIOUSLY CITED) and further in view of Burnett et al (U.S. Patent Application Publication Number: US 2008/0249467 A1, hereinafter “Burnett”).
Regarding claims 7-9, 13-15 and 19-20, Tockman in view of Rothenberg OR Katims teaches the claimed invention as discussed above except for detecting, with a second sensor, blood- filled structures, wherein the advancement avoids the blood-filled structures and the detecting with the second sensor comprising sensing differences in temperature between blood-filled structures and surrounding tissue and the detecting with the second sensor comprising sensing differences in light absorption of the tissue.
In a similar field of endeavor, Burnett teaches a system and method for providing access to an anatomical space outside of a vasculature space( e.g. [0018]-[0020]) comprising an instrument that has an elongate body 2 with an anatomical space sensor 4 at its distal end which may intermittently or continuously provide information to the user to sense a parameter identifying an anatomical space (e.g. [0048]) and sensing differences in temperature between blood filled structures and surrounding tissue (e.g. [0020]: the step of generating a location indication includes the step of sensing a parameter with the anatomical space sensor, such as an electrical property, temperature) and changes in optical properties such as refraction of light within the tissue (e.g. [0042], [0048]). Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the method in the teachings of Tockman in view of Rothenberg OR Katims to include a second sensor that senses tissue properties such as temperature and light refraction outside of the vasculature in order to provide the predictable results of ensuring the target region is safely reached.
Claims 7, 9, 10, 13, 15 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Tockman et al (U.S. Patent Application Publication Number: US 2006/0047333 A1, hereinafter “Tockman”) in view of Rothenberg (U.S. Patent Number: US 7794407, hereinafter “Rothenberg”- PREVIOUSLY CITED) OR Katims (U.S. Patent Number: US 5078678, hereinafter “Katims”- PREVIOUSLY CITED) and further in view of Wood et al (U.S. Patent Application Publication Number: US 8391960, hereinafter “Wood”).
Regarding claims 7, 9, 10, 13, 15 and 16, Tockman in view of Rothenberg OR Katims teaches the claimed invention as discussed above except for sensing differences in light absorption of the tissue and the detecting with the second sensor comprising scanning laser light across a surface of the patient to determine the location of subcutaneous blood-filled structures.
In a similar field of In a similar field of endeavor, Wood teaches use of one or more moving laser light sources to detect the presence of blood-filled structures, such as venous or arterial structures, below the surface of the skin and to project an image back on to the skin that shows the operator the pattern of detected structures ( e.g. Col. 2 lines 40-45) and therefore they teach sensing differences in light absorption of the tissue and scanning laser light across a surface of the patient to determine the location of subcutaneous blood-filled structures (e.g. Fig.7A, Col. 12 line 35 col 13 line 7). Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the method in the teachings of Tockman in view of Rothenberg OR Katims to include a second sensor that senses differences in light absorption of the tissue by scanning laser light across a surface of a patient to determine a location of subcutaneous blood filed structures as taught by Wood in order to provide the predictable results of safely inserting the lead into the tissue and reduce unnecessary blood loss.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Thomson-Nauman et al (U.S. Patent Application Publication Number: US 2015/0322627 A1, hereinafter “Thompson-Nauman”) teaches implantation of a lead in a cavity of the mediastinum (e.g. abstract, Figs.1,11)
Silipo et al (U.S. Patent Application Publication Number: US 2010/0082087 A1, hereinafter “Silipo”) teaches a method of implanting an implantable patient lead including advancing a lead implantation assembly towards a desired target location along an introduction axis and monitoring at least one indicator of lead implantation assembly position along the lead introduction axis (e.g. abstract) . The introducer sensor 222 is configured to provide signals or other indicia 223 as the system 200 proceeds along the introduction or implantation direction and further configured to provide a signal or other indicia as the introducer 202 engages with the target tissue 150. In one embodiment, the introducer sensor 222 comprises is further adapted to sense a local electrical impedance adjacent the distal end 204 of the introducer 202 (e.g. [0038).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MALLIKA DIPAYAN FAIRCHILD whose telephone number is (571)270-7043. The examiner can normally be reached Monday- Friday 8 am-5pm EST.
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/MALLIKA D FAIRCHILD/Primary Examiner, Art Unit 3792
